Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1250](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1250) → PPN — Percutaneous Catheter, Ultrasound

# PPN · Percutaneous Catheter, Ultrasound

_Cardiovascular · 21 CFR 870.1250 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PPN

## Overview

- **Product Code:** PPN
- **Device Name:** Percutaneous Catheter, Ultrasound
- **Regulation:** [21 CFR 870.1250](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1250)
- **Device Class:** 2
- **Review Panel:** [Cardiovascular](/submissions/CV)

## Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

## Classification Rationale

Class II (performance standards).

## Recent Cleared Devices (12 of 12)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K250225](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PPN/K250225.md) | Bolt Intravascular Lithotripsy (IVL) System | Bolt Medical, Inc. | Mar 25, 2025 | SESE |
| [K242213](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PPN/K242213.md) | Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter | Shockwave Medical, Inc. | Sep 27, 2024 | SESE |
| [K240954](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PPN/K240954.md) | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | Shockwave Medical, Inc. | May 7, 2024 | SESE |
| [K240225](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PPN/K240225.md) | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter | Shockwave Medical, Inc. | Mar 22, 2024 | SESE |
| [K221852](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PPN/K221852.md) | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter | Shockwave Medical, Inc. | Aug 16, 2022 | SESE |
| [K221041](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PPN/K221041.md) | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System | Shockwave Medical, Inc. | Apr 25, 2022 | SESE |
| [K203365](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PPN/K203365.md) | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter | Shockwave Medical, Inc. | Apr 22, 2021 | SESE |
| [K191840](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PPN/K191840.md) | Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) | Shockwave Medical, Inc. | Aug 7, 2019 | SESE |
| [K180958](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PPN/K180958.md) | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable | Shockwave Medical, Inc. | Jul 26, 2018 | SESE |
| [K180454](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PPN/K180454.md) | Shockwave Medical Intravascular Lithotripsy (IVL) System | Shockwave Medical, Inc. | Jun 27, 2018 | SESE |
| [K163306](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PPN/K163306.md) | Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable | Shockwave Medical, Inc. | Dec 22, 2016 | SESE |
| [K161384](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PPN/K161384.md) | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector Cable, Lithoplasty Connector Cable | Shockwave Medical, Inc. | Sep 14, 2016 | SESE |

## Top Applicants

- Shockwave Medical, Inc. — 11 clearances
- Bolt Medical, Inc. — 1 clearance

---

**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PPN](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/PPN)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com